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In Brief: Device MRA talks

This article was originally published in The Gray Sheet

Executive Summary

Device MRA talks: FDA and European Union negotiators fail to resolve differences over a device mutual recognition agreement during round of talks in Brussels Jan. 6-10. The EU maintains its position that a device MRA include recognition of approvals and inspections, while FDA remains committed to an inspection-only pact. EU officials also are "rethinking" an agreement on pharmaceuticals forged during November's Trans-Atlantic Business Dialogue meeting in Chicago, according to Department of Commerce staffers. In a continued push to meet President Clinton's December pledge of finalizing an agreement by Jan. 31 ("The Gray Sheet" Dec. 23, p. 3), U.S. trade reps are inviting EU officials to Washington to resume talks. A meeting is expected to take place during the week of Jan. 27...
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